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学位を持っても、センスのない、感染制御専門薬剤師のブログ.  I have Ph.D. but less sense ID pharmacist.

Adverse Events and Antibiotic Use in Hospitalized Patients

Adverse Events and Antibiotic Use in Hospitalized Patients




2017年6月 JAMA Intern Med に報告された、 Johns Hopkinsの総合内科による入院患者の抗菌薬に関する副作用出現を検討したレトロスペクティブ研究。




Key Points

Question  What is the likelihood of developing antibiotic-associated adverse drug events (ADEs) for hospitalized patients receiving antibiotic therapy?

Findings  In this cohort study, medical records of 1488 adult inpatients were examined for 30 days after antibiotic initiation for the development of the following antibiotic-associated ADEs: gastrointestinal, dermatologic, musculoskeletal, hematologic, hepatobiliary, renal, cardiac, and neurologic; and 90 days for the development of Clostridium difficile infection or incident multidrug-resistant organism infection. Twenty percent of patients experienced at least 1 antibiotic-associated ADE.

Meaning  These findings underscore the importance of judicious antibiotic prescribing to reduce the harm that can result from antibiotic-associated ADEs.



P : adult inpatients admitted to general medicine wards

E : At least 24 hours of any parenteral or oral antibiotic therapy

C : NO

O : 

A total of 298 (20%) patients experienced at least 1 antibiotic-associated ADE. Furthermore, 56 (20%) non–clinically indicated antibiotic regimens were associated with an ADE, including 7 cases of C difficile infection.

Every additional 10 days of antibiotic therapy conferred a 3% increased risk of an ADE.

The most common ADEs were gastrointestinal, renal, and hematologic abnormalities, accounting for 78 (42%), 45 (24%), and 28 (15%) 30-day ADEs, respectively. 

T : Retrospective cohort 














This was a single-center study at an academic hospital with a medically complex patient population.

Replication of our results at other institutions and in other patient populations is necessary to enhance the generalizability of our findings.

This would also allow for ADE estimates for antibiotic agents not included on our hospital formulary.

Furthermore, because prescriptions of some antibiotics were so infrequent (eg, penicillin, ceftaroline fosamil, tigecycline), accurate estimates of some drug specific ADEs could not be calculated.

Our approximations of antibiotic-associated ADEs are likely underestimations for a number of reasons.

First, our hospital has had a robust antibiotic stewardship program since 2002 that remained active during the study period, likely reducing overall antibiotic prescriptions, durations of antibiotic therapy, and consequently antibiotic-associated ADEs.

Second, we were unable to evaluate data from patients who had follow-up medical care outside the Epic Care Everywhere network, for example those who presented to primary care clinicians, emergency departments, or urgent care centers not using the Epic electronic medical record system.

Of note, only 119 (8%) patients were considered lost to follow up with no subsequent inpatient or outpatient visits documented in the Epic Care Everywhere network.

Additionally, it is plausible that a portion of patients in this cohort may have previously experienced serious antibiotic- associated ADEs, leading to future avoidance of these agents (eg, hives from penicillin use as a child), also potentially underestimating the incidence of antibiotic-associated ADEs.

Finally, we did not include excessively prolonged durations of antibiotic therapy or inappropriately broad antibiotic use toward our calculation of avoidable antibiotic- associated ADEs, likely underestimating this value.